BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 12094492 · Received June 30, 2021

    Report

    Report Number
    2182207-2021-01160
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 22, 2020
    Report Date
    July 20, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID 8637-20 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6)2015. PRODUCT TYPE PUMP PRODUCT ID NEU _ASCENDA_CATH LOT# SERIAL# UNKNOWN EXPLANTED: (B)(6)2020 PRODUCT TYPE CATHETER PRODUCT ID 8637-20 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6)2015 PRODUCT TYPE PUMP THE PREVIOUSLY REPORTED INFORMATION (ASPIRATION PRIOR TO FILLING PUMP AND FLUID COLLECTION) WILL NO LONGER BE REPORTED UNDER THIS MA NUFACTURING REPORT AS SPECIFIC DEVICE INFORMATION WAS RECEIVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THE PUMP AND CATHETER WERE REMOVED ON (B)(6)2020 AND DEVICE INFORMATION (IMPLANT DATE AND SERIAL NUMBERS) WERE PROVIDED. A NEW PUMP WAS IMPLANTED ON (B)(6)2020. IT WAS NOTED THAT THE REMOVED DEVICES WERE NOT AVAILABLE. THE EVENTS BEGAN ON (B)(6)2020. IT WAS NOTED THAT NO CAUSE HAS BEEN CLEAR IDENTIFIED. ONE HYPOTHESIS WOULD BE A SHOCK NEXT TO THE PUMP WAS RESPONSIBLE FOR AN UNNOTICED SKIN LESION. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CITATION: DE LARMINAT, V., ZAYET, S., KLOPFENSTEIN, T., IDELCADI, M. STREPTOCOCCUS DYSGALACTIAE-RELATED INTRATHECAL BACLOFEN THERAPY INFECTION: HOW TO AVOID WITHDRAWAL?. NEW MICROBES AND NEW INFECTIONS. 2021; 41: 100875. B3: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8637 LOT# SERIAL# UNKNOWN IMPLANTED: (B)(6) 2015 EXPLANTED: PRODUCT TYPE PUMP PRODUCT ID NEU_ASCENDA_CATH LOT# SERIAL# UNKNOWN IMPLANTED: (B)(6) 2008 EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8637 LOT# SERIAL# UNKNOWN IMPLANTED: (B)(6) 2015 EXPLANTED: PRODUCT TYPE PUMP INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_ASCENDA_CATH, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: INTRATHECAL BACLOFEN THERAPY IS COMMONLY USED FOR NEUROLOGICALLY SPASTIC PATIENTS. ONE OF THE MAJOR COMPLICATIONS IS HARDWARE INFECTION, WHICH GENERALLY REQUIRES URGENT REMOVAL OF THE PUMP AND THE INTRATHECAL CATHETER, WITH THE RISK OF SEVERE BACLOFEN WITHDRAWAL. WE HAVE RECENTLY BEEN FACING THIS SITUATION AND PROPOSE ANOTHER SOLUTION WITH ADAPTED ANTIBIOTIC THERAPY, REMOVAL WITH IMMEDIATE REPLACEMENT OF THE INTRATHECAL CATHETER, INITIALLY CONNECTED TO AN IMPLANTED PORT TO CONTINUE BACLOFEN ADMINISTRATION. A NEW PUMP WAS SECONDARILY IMPLANTED, AFTER SUCCESSFUL TREATMENT OF ACUTE BACTERIAL MENINGITIS DUE TO STREPTOCOCCUS DYSGALACTIAE. TO OUR KNOWLEDGE, WE REPORT HEREIN THE FIRST CASE OF INTRATHECAL BACLOFEN THERAPY INFECTION CAUSED BY STREPTOCOCCUS DYSGALACTIAE, IN (B)(6). REPORTED EVENT: A (B)(6) YEAR-OLD WOMAN HAS BEEN PARAPLEGIC SINCE THE AGE OF 19 YEARS, AFTER A PUBLIC ROAD ACCIDENT. SHE WAS IMPLANTED FOR INTRATHECAL THERAPY IN 2008 WITH AN ASCENDA CATHETER AND SYNCHROMED II PUMP (MEDTRONIC, DUBLIN, IRELAND), INITIALLY FOR BACLOFEN ALONE, AND THEN ASSOCIATED WITH MORPHINE FOR NEUROPATHIC PAIN. DOSES WERE UNCHANGED FOR 10 YEARS, WITH DAILY ADMINISTRATION OF 300 ¿G OF BACLOFEN AND 400 ¿G OF MORPHINE (ONCE A DAY). FILLINGS WERE SCHEDULED EVERY 10 WEEKS. SHE IS A VERY AUTONOMOUS AND DYNAMIC WOMAN, PERFORMING URINARY CATHETERIZATIONS HERSELF, DAILY RE-EDUCATION AND TRANSFERS IN HER WHEELCHAIR. PUMP REPLACEMENT WAS PERFORMED IN 2015, WITHOUT ANY TROUBLE. PROGRESSIVELY THEREAFTER, A LYMPHATIC COLLECTION SETTLED AROUND THE PUMP, REQUIRING REGULAR ASPIRATIONS OF UP TO 200 ML OF YELLOW LIQUID BEFORE FILLING, TO GAIN ACCESS TO THE FILLING PORT. GRADUALLY, AFTER SEVERAL MONTHS, THE DIFFUSION DRIED UP, SIMPLIFYING SUBSEQUENTFILLINGS, FROM 2017. ON (B)(6) (DAY 1) THE WOMAN PRESENTED TO THE EMERGENCY DEPARTMENT WITH A 24-HOUR HISTORY OF FEVER, CHILLS AND FATIGUE. ON ADMISSION, NEUROLOGICAL EXAMINATION SHOWED A GLASGOW COMA SCALE SCORE OF 15/15 (E = 4, V = 5, M = 6) WITH NO NECK STIFFNESS OR FOCAL ABNORMALITIES. SHE ONLY COMPLAINED ABOUT NAUSEA AND A CLOUDY LIQUID ISSUING FROM A SMALL HOLE (THROUGH WHICH THE PUMP WAS APPARENT) IN THE AREA OF THE PUMP WITH AN INDURATED ZONE SURROUNDING IT. QUICK SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE (QSOFA) WAS EVALUATED ON TWO OCCASIONS. ROUTINE LABORATORY FINDINGS SHOWED ELEVATED C-REACTIVE PROTEIN (150 MG/L). ANTIBIOTHERAPY WAS BEGUN IMMEDIATELY AFTER TAKING BLOOD SAMPLES AND A FLUID SAMPLE FROM THE PUMP SCAR FOR CULTURES. LUMBAR PUNCTURE WAS DEFERRED BECAUSE OF ANTICOAGULANT TREATMENT (FLUINDIONE) INTRODUCED YEARS AGO FOR REPETITIVE PHLEBITIS. ANTIMICROBIAL DRUGS WERE VANCOMYCIN (15 MG/KG LOADING DOSE THEN 60 MG/KG/24 H GIVEN AS A CONTINUOUS INFUSION) AND CEFOTAXIME (300 MG/KG/24 H BY INTRAVENOUS INFUSIONS SIX TIMES DAILY). THE CHALLENGE WAS TO TREAT AN INFECTION ON NEUROLOGICAL MATERIAL THAT REQUIRED ITS URGENT REMOVAL, AND, IF PERFORMED, WITHDRAWAL OF BACLOFEN, WHICH COULD ALSO BE LIFE-THREATENING. AS THE INFECTION TOLERANCE WAS EXCELLENT WITH VERY FEW GENERAL AND MENINGEAL SIGNS, WITH RAPID DECREASE OF FEVER AND BIOLOGICAL INFL AMMATORY SYNDROME WITHIN THE FIRST 24 H (CREACTIVE PROTEIN 80 MG/L), IT WAS PROPOSED ATTEMPT MEDICAL TREATMENT AFTER LOCAL SURGICAL CLEANING OF THE SITE OF THE PUMP ON (B)(6) (DAY 2). A CEREBROSPINAL FLUID (CSF) SAMPLE WAS COLLECTED, THANKS TO THE DIRECT ACCESS TO THE CATHETER AT THE TOP OF THE PUMP. ANALYSIS OF THE PURULENT CSF REVEALED AN ELEVATED WHITE BLOOD CELL COUNT OF 660/MM3 WITH 90% NEUTROPHILS WITH ELEVATED PROTEIN CONCENTRATION (4.31 G/L) AND LOW GLYCORRHACHIA (GLUCOSE CONCENTRATION 0.8 MMOL/L). BLOOD CULTURES WERE NEGATIVE. DIRECT EXAMINATION OF CSF REVEALED GRAM-POSITIVE COCCI AND THE CULTURE ISOLATED A STREPTOCOCCUS DYSGAL ACTIAE. PCR AMPLIFICATION AND SEQUENCE ANALYSIS DETERMINED THE SAME PATHOGEN. THE S. DYSGALACTIAE WAS A STRAIN SUSCEPTIBLE TO ALL ANTIBIOTICS ON ANTIMICROBIAL SUSCEPTIBILITY TESTING. CULTURE OF A SCAR SWAB ALSO ISOLATED AN S. DYSGALACTIAE. FOLLOW-UP CSF CULTURE AFTER ADMINISTRATION OF ANTIBIOTICS WAS STERILE. AFTER THESE RESULTS, ANTIBIOTICS WERE SWITCHED TO AMOXICILLIN (200 MG/KG BY SIX INTRAVENOUS INFUSIONS DAILY) AND RIFAMPICIN (900 MG DAILY, ORALLY). THE PATIENT WAS INITIALLY HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR 3 DAYS, AND THEN TRANSFERRED TO THE INFECTIOUS DISEASES DEPARTMENT. PROGRESS WAS INITIALLY FAVOURABLE, WITH DECREASE OF FEVER, DISAPPEARANCE OF NAUSEA AND HEADACHE, AND BIOLOGICAL IMPROVEMENT WITH REGRESSION OF THE INFLAMMATORY SYNDROME. NEVERTHELESS, THE PERSISTENCE OF A FEBRICULA AND THE ABSENCE OF BIOLOGICAL NORMALIZATION LED US TO PERFORM THE ABLATION OF THE PUMP AND INTRATHECAL CATHETER ON (B)(6) (DAY 9). DURING THE SAME OPERATION, A NEW INTRATHECAL CATHETER (ASCENDA 8780, MEDTRONIC) WAS PLACED, TUNNELLED TO THE RIGHT HYPOCHONDRIUM AND LINKED TO AN IMPLANTED PORT (CELSIT). THIS PORT WAS CONNECTED TO AN EXTERNAL PUMP, WHICH ALLOWED THE CONTINUOUS ADMINISTRATION OF THE INTRATHECAL THERAPY AT THE USUAL DOSES FOR THIS PATIENT. ON (B)(6) (DAY 17), REPLACEMENT OF THE IMPLANTED PORT BY A NEW SYNCHROMED II PUMP WAS DECIDED ON, CONSIDERING THE FAVOURABLE CLINICAL AND BIOLOGICAL EVOLUTION AFTER 16 DAYS OF EFFECTIVE ANTIBIOTHERAPY. THE PORT WAS DISCONNECTED FROM THE CATHETER, WHICH WAS TUNNELLED UP TO THE NEW POSITION OF THE IMPLANTED PUMP, ON THE OPPOSITE ABDOMINAL SIDE TO THE INITIAL SITE. THE PATIENT WAS DISCHARGED FOR OUTPATIENT FOLLOW UP AFTER 18 DAYS OF HOSPITALIZATION. ANTIBIOTIC THERAPY WAS PROLONGED AT HOME UP TO 15 FULL DAYS AFTER THE REMOVAL OF SEPTIC MATERIAL. TWO MONTHS AFTER THE END OF THE ANTIBIOTICS THE WOMAN WAS SEEN (FOR FILLING OF HER PUMP); SHE WAS CURED OF THIS ACUTE EPISODE, DESPITE SOME DIFFICULTIES IN TOTAL RECOVERY OF HER AUTONOMY. THIS CASE REPORT DEMONSTRATES THAT TEMPORARY USE OF AN EXTERNAL PUMP CONNECTED TO A PORT AND INTRATHECAL CATHETER MAY BE A USEFUL ALTERNATIVE TO AVOID INTRATHECAL THERAPY WITHDRAWAL, EVEN IN THE CASE OF SEPSIS. IT REMAINS TO BE DETERMINED FOR HOW LONG ANTIBIOTHERAPY SHOULD BE ADMINISTERED BEFORE REMOVAL OF THE MATERIAL AND HOW LONG WE SHOULD WAIT BEFORE IMPLANTATION OF A NEW MATERIAL. THERE ARE ONLY OLD RECOMMENDATIONS WITH A LOW EVIDENCE LEVEL. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989208 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R